The Effect of Obesity and Weight Loss in Heart Failure With Preserved Ejection Fraction

Not Applicable

Recruiting

• Conditions: Obesity; Heart Failure With Preserved Ejection Fraction
• Interventions: Other: Diet intervention

• Registration Number: NCT05878912
• Lead Sponsor: University of Oxford

Brief Summary

This study looks at the effects of weight loss in people who have heart failure with preserved ejection fraction (HFpEF) and are overweight or obese.

The main questions it aims to answer are whether weight loss in this group of people improves:

1. The heart's shape, how well it pumps blood and how well it uses fuels

2. The person's quality of life and how much they can exercise

Participants will attend 2 study visits, separated by 3-6 months. The intervention period takes place in between the 2 study visits.

Each study visit will involve measurements including:

* Symptom and quality of life questionnaires

* Body measurements such as height and weight

* Blood tests

* Ultrasound scans of the heart (echocardiogram)

* Magnetic Resonance Imaging (MRI) scans of the heart

* Exercise components during the scans

* 6 minute walk test

Participants are randomly allocated (in other words, by lottery) to either 'diet' or 'control' groups. The control group will continue standard care.

The diet group will be enrolled in a weight loss program supervised by the study team. Participants in the diet group will replace their usual meals with meal replacement products specifically designed to deliver a low calorie diet for weight loss. The products will consist of formula soups, shakes and porridges. This diet would last 8 weeks, followed by a guided period of food reintroduction and maintenance.

Detailed Description

An interim analysis is planned at 60 recruits to review the recruitment target.

Study Timeline

• Study Start: 2023-01-20
• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-05-23
• Study First Posted: 2023-05-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24
• Primary Completion: 2025-10
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Heart failure with preserved ejection fraction (HFpEF)
• Left ventricular ejection fraction (LVEF) =/> 50%
• Body Mass Index (BMI) approximately =/> 27.5 kg/m^2

Exclusion Criteria

• Contraindications to magnetic resonance imaging
• NYHA class IV
• Significant valvular, ischemic, infiltrative or other potentially confounding cardiac disease
• Pregnancy, planned pregnancy or lactating
• Any other conditions which may potentially compromise the safety or scientific validity of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet	Diet intervention	Diet intervention (in addition to standard clinical care)

Primary Outcome Measures

Name	Time	Method
Left atrial volume	Change from baseline at 3-6 months	measured on cardiac magnetic resonance imaging

Secondary Outcome Measures

Name	Time	Method
Body weight	Change from baseline at 3-6 months
Six minute walk distance	Change from baseline at 3-6 months
N-terminal pro brain natriuretic peptide (NT pro BNP)	Change from baseline at 3-6 months
Kansas City Cardiomyopathy Questionnaire (KCCQ)	Change from baseline at 3-6 months	Score of 0 to 100, High scores indicate better outcome

Trial Locations

Locations (1)

Oxford Centre for Clinical Magnetic Resonance Research, John Radcliffe Hospital; 🇬🇧 Oxford, United Kingdom